Validation of Computerized Analytical Systems - Ludwig Huber - 图书 - Taylor & Francis Ltd - 9780367401726 - 2019年10月7日
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Ludwig Huber
Validation of Computerized Analytical Systems 第1 版本

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Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.

International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

264 pages

介质类型 图书     Paperback Book   (平装胶订图书)
已发行 2019年10月7日
ISBN13 9780367401726
出版商 Taylor & Francis Ltd
页数 268
商品尺寸 150 × 220 × 10 mm   ·   453 g
语言 英语  

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